Home NDC 85050-012 Serawise Eczema Relief
Product NDC 85050-012
11-digit product format 850500012
Labeler code 85050
Product ID 85050-012_59ee6025-96de-ec6d-e063-6294a90acfdd
Type HUMAN OTC DRUG
Nonproprietary name OATMEAL
Dosage form CREAM
Route TOPICAL
Labeler DrAnaMaria. Com LLC
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-08-14
Substance OATMEAL
Active strength 10 mg/mL
Pharmacologic classes Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Serawise Eczema Relief
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OATMEAL 10 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8PI54V663Y Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 240651 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 45 of 68 · 1,346 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85050-012-00 85050001200 1 JAR in 1 BOX (85050-012-00) / 118.29 mL in 1 JAR 1 jar 2026-08-14 No No Current